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Ethics, Morals and Regulation: Proactive Thinking at iGEM

One of the primary points of emphasis at iGEM is encouraging teams to think about the consequences of their science. As part of each presentation, the students discuss potential implications of their work in terms of morals/ethics, regulation, and public acceptance. Judges often follow up with questions about issues such as IRB approval, and ask participants to discuss their view on potential drawbacks or barriers to getting a product to market.

In addition, iGEM scheduled several workshops to cover these issues throughout the conference. One, hosted by the FBI called “Safeguarding Science,” includes an open discussion table and a talk scheduled for tomorrow afternoon. Another is a series hosted by the EU-funded project Synenergene. At lunch both yesterday and today, Synenergene held workshops called “Looking Ahead.” Evenings include sessions called “Frame Reflection,” which helped attendees understand their worldview and how it compares to the worldview of others. I attended the former, and came away impressed by how thoroughly Synenergene is examining the long-term ramifications of synthetic biology and trying to anticipate problems.

Today, the session revolved around presentations by four iGEM teams that received grants from Synenergene to participate (another four will present later in the meeting). The goal was for each group to consider how to “facilitate a meaningful dialogue on emerging technology without too much speculation.” In other words, how can synthetic biologists take a new technology (in this case the project being developed by each team), and realistically discuss future issues without drifting into fantasy and what-ifs in order to avoid fear and unnecessary opposition. In particular, an emphasis was placed on looking at 1) the need for a product, 2) the rules and regulations that might apply to that product and 3) public acceptance of the product.

Teams were asked to take the application of their project and first examine its plausibility. Then, they were instructed to consider the desirability of their product in an attempt to (non-speculatively) discuss the ethics and morals and develop a “techno-moral vignette.” For example, TU Eindhoven is developing an oil-eating bacterium. They wrote a vignette discussing both the benefits of having a viable bioremediation option for cleaning oil spills and the concerns about letting such a genetically engineered organism into the wild.

Yesterday, the workshop was called “Safe by Design” and was hosted by the Dutch National Institute for Public Health and the Environment (RIVM) in conjunction with Synenergene. In it, groups were asked to look at issues arising at the “gates” to each step of a simplified product development model for one of three case-studies. Stage 1 was “Basic Research,” Stage 2 was “Product Development” and Stage 3 was “Launch and Operations.” Each gate consisted of the criteria needed to complete the stage and “reduce the level of uncertainty in the decision making process…For example, to launch a product in the environment you must have thought about: tests [to prove safety], social acceptance, [and] regulations.”

Intriguingly, the workshop seemed to be designed not only to help attendees think about this process, but also to help RIVM generate ideas to use as they work on developing sound policy. Thus, it was encouraging to see not only young scientists thinking through the ethical and societal issues surrounding synthetic biology, but to see policy teams working to get ahead of these issues. One can hope that the results of exercises such as these will eventually be manifest in a more streamlined research pipeline and improved communication between scientists, the public and policy makers. Young scientists who go into research and product development will already have practice thinking proactively about potential concerns. Additionally, if these types of exercises are widely used, sound policy will stand a much better chance of staying ahead of emerging (and potentially controversial) technologies. Furthermore, scientists will likely be more engaged with policy makers, while the latter will be primed to better understand the perspectives of the former. Finally, if the public participates with scientists in these preemptive discussions, it will likely lead to better understanding of the technology on the part of the public, and increased empathy for the concerns of the public on the part of scientists. In the end, better communication means less frustration on all sides, which in turn means a higher chance of successfully implementing valuable new tools born out of synthetic biology.

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2 comments

JM, thanks for your comment and important insight. This question about the non-linearity of product development was briefly raised at the session. It is something I would have like to have heard more discussion on; however, I think for the sake of time the facilitators kept it brief. Their response was, for the sake of the exercise, to assume linearity, but in reality to recognize the need to be continually considering all three gates simultaneously.

I’n my mind, scientists working at the early/basic research stage should be preemptively engaging in discussion about the second gate in order to communicate why they are doing basic research. Put another way, because the arrows point in both directions between stages of the real product development cycle, there are times when the discussion or gate to stage 2 or 3 will dictate what happens when transitioning back into stage 1. The policing of issues related directly to basic research (stage 1), such as IRB approvals, safety, animal models, etc., will be affected by the risk/benefit analysis in terms of future applications (stages 2&3).

Because the question is about an inherently non-linear, multi-dimensional system, It’s not an easy one to answer. I’d be very interested to hear the thoughts of the community on how to deal with it.

very interesting summary. I guess my observation is what form does this intervention take at “basic research”? in other words what is the criteria used at this first gate? My concern is that there rarely is a linear move from basic research to commercial product, such a development is non linear,so this current iteration of the model presuposes preciely this. the concern is that this may lead to an egregious policing of the scientific imagination at a very early stage. how can this be avoided?